pemetrexed disodium in treating patients with ovarian epithelial cancer or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

objectives: * determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols. * determine the nature and degree of toxicity of this drug in these patients. outline: this is a multicenter study. patients receive pemetrexed disodium iv over 10 minutes on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin b_12) intramuscularly every 9 weeks. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 19-51 patients will be accrued for this study within 11-22 months.

Eligibility criteria:
disease characteristics: * histologically confirmed ovarian epithelial or primary peritoneal cancer * recurrent or persistent disease * measurable disease * at least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, ct scan, or mri) or ≥ 10 mm by spiral ct scan * tumors within a previously irradiated field are considered non-target lesions * must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease * initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel * platinum-resistant or refractory disease * treatment-free interval \< 6 months after prior platinum-based therapy or progressed during platinum-based therapy * not eligible for a higher priority gog protocol (i.e., any active phase iii gog protocol for the same patient population) patient characteristics: age * any age performance status * gog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9 g/dl hepatic * bilirubin ≤ 1.5 times upper limit of normal (uln) * alkaline phosphatase ≤ 3 times uln\* * ast and alt ≤ 3 times uln\* note: \* ≤ 5 times uln if due to hepatic metastases renal * creatinine clearance ≥ 45 ml/min other * no other malignancy within the past 5 years except nonmelanoma skin cancer * no neuropathy (sensory or motor) \> grade 1 * no active infection requiring antibiotics * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for at least 3 months after study treatment prior concurrent therapy: biologic therapy * one prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following: * monoclonal antibodies * cytokines * small-molecule inhibitors of signal transduction * at least 3 weeks since prior biologic or immunologic therapy * at least 24 hours since prior growth factors * no concurrent routine colony-stimulating factors chemotherapy * see disease characteristics * recovered from prior chemotherapy * no prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens * no prior pemetrexed disodium endocrine therapy * at least 1 week since prior hormonal therapy for the malignant tumor * concurrent hormone replacement therapy allowed radiotherapy * see disease characteristics * no prior radiotherapy to \> 25% of bone marrow * at least 2 weeks since prior radiotherapy and recovered surgery * recovered from prior surgery other * no prior cancer treatment that would preclude study participation * no non-steroidal anti-inflammatory drugs (nsaids) for 2-5 days before, during, and for 1-2 days after study drug administration * concurrent low-dose (≤ 325 mg/day) aspirin allowed * at least 3 weeks since other prior therapy for the malignant tumor

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer